The effect of using letrozole alone protocol versus using letrozole and HCG protocol on induction of ovulation in polycystic ovarian syndrome patients: A prospective cohort study

Abstract: Background: This study aims to challenge the routine use of HCG in simple letrozole induction protocols, suggesting its limited necessity in specific cases, potentially reducing costs and stress for infertile couples. Material and Methods: This is a prospective cohort study was done at the assisted reproductive unit in Ahmed Maher teaching hospital in Cairo. The study includes 132 infertile women aged 18 to 35 with PCOS, free from other medical disorders and not taking conflicting medications. Prerequisites involve normal hysterosalpingography and semen analysis. Participants were evenly divided into two groups: the first receiving letrozole exclusively for ovulation induction, and the second receiving letrozole with HCG when suspected ovulation maturity occurred. Following a 2-week period, both groups underwent a pregnancy test, and individuals with positive results received a transvaginal ultrasound one week later for clinical pregnancy confirmation. Results: Positive pregnancy tests were identical in both groups (15 women, 22.7%, P-value = 1). Regarding clinical pregnancy, the Letrozole-only group exhibited 14 pregnancies (21.2%), slightly higher than the Letrozole+HCG group with 13 pregnancies (19.7%), though the difference was statistically non-significant (p-value = 0.829). Conclusion: The study suggests a slightly higher effectiveness of the letrozole-only protocol for fertility treatment in women with polycystic ovary syndrome, specifically regarding clinical pregnancy, compared to the letrozole+HCG protocol. The findings further recommend limiting HCG use to cases necessitating intrauterine insemination or for individuals diagnosed with luteinized unruptured follicle syndrome. Keywords: Letrozole, PCO, Induction of ovulation, Infertility摘要： 研究背景：本研究旨在挑战简单来曲唑（Letrozole）促排卵方案中常规使用人绒毛膜促性腺激素（Human Chorionic Gonadotropin，HCG）的临床实践，提出在特定场景下其必要性有限，有望降低不孕夫妇的治疗成本与心理压力。 材料与方法：本研究为一项前瞻性队列研究，于开罗艾哈迈德·马赫教学医院辅助生殖科室开展。研究纳入132名年龄介于18至35岁的不孕女性，均确诊为多囊卵巢综合征（Polycystic Ovary Syndrome，PCOS），无其他内科疾病，且未服用存在药物相互作用的药物。本研究的纳入标准包括子宫输卵管造影（Hysterosalpingography）结果正常及精液分析（Semen Analysis）合格。参与者被平均分为两组：第一组仅接受来曲唑进行促排卵治疗，第二组在疑似排卵成熟时接受来曲唑联合人绒毛膜促性腺激素（HCG）治疗。接受治疗两周后，两组均接受妊娠检测，结果阳性者于一周后接受经阴道超声（Transvaginal Ultrasound）检查以确认临床妊娠状态。 结果：两组的妊娠检测阳性率完全一致，均为15例（占比22.7%），P值=1。就临床妊娠结局而言，单纯来曲唑组的临床妊娠数为14例（占比21.2%），略高于来曲唑联合HCG组的13例（占比19.7%），但该差异无统计学意义（P值=0.829）。 结论：本研究结果显示，针对多囊卵巢综合征不孕女性，仅使用来曲唑的促排卵方案在临床妊娠率方面的有效性略优于来曲唑联合HCG方案。研究结果进一步建议，仅在需实施宫腔内人工授精（Intrauterine Insemination）的患者，或确诊为未破裂卵泡黄素化综合征（Luteinized Unruptured Follicle Syndrome）的人群中使用人绒毛膜促性腺激素。 关键词：来曲唑，PCO，促排卵，不孕